Downstream Manufacturing Associate III (Wed-Sat 4/3 Overnight Shift, 6p-6:30a)

Job Summary

Required Qualifications

• •High school diploma
• •3-6 years of related experience
• •Associate degree in Life Sciences/Engineering field
• •Biotech Certificate
• •Bachelor's degree
• •1-4 years of related experience
• •Demonstrated knowledge of CGMP manufacturing
• •Knowledge of laboratory and pharmaceutical production equipment
• •Able to read and follow detailed written instructions
• •Good verbal/written communication skills
• •Able to write legibly and grammatically correct entries on records
• •Able to author technical procedures and create forms
• •Familiar with standard troubleshooting approaches
• •Good computer skills
• •Knowledge of Microsoft Word, Excel
• •Good interpersonal skills
• •Ability to work effectively and efficiently in a team environment
• •Ability to meet schedule required
• •Ability to work in a clean room environment
• •Compliance with hygiene standards
• •Use of special garments
• •Wearing of personal protective equipment
• •May require lifting amounts of 25 lbs
• •Ability to regularly remain on feet for shift
• •Experience with GMP downstream manufacturing
• •Experience with TFF, Chromatography systems and purification of Mabs
• •Experience with Akta ready, Akta Process, XDUos buffer systems and disposable technology systems
• •Experience with troubleshooting of the equipment and of process
• •Excellence in clinical manufacturing
• •Adaptable to changes
• •Ability to work cross functionally and with key stakeholders
• •Self-motivated
• •Takes initiative and drives for solutions with the team
• •Ability to lead in the absence of the manager
• •Ability to train newer operators once up to speed
• •Strong knowledge and understanding of manufacturing process and equipment
• •Ability to train employees
• •Subject matter expert operating production equipment
• •Ability to monitor and record batch parameters
• •Ability to complete relevant paperwork following GDP/GMP guidelines
• •Ability to perform mathematical calculations related to production processes
• •Ability to initiate new documents for procedures
• •Ability to make minor revisions to existing documents
• •Ability to work with support team on event investigations
• •Ability to perform inventory system cycle counts and discrepancies
• •Ability to troubleshoot process problems and respond to alarms
• •Ability to provide information for unplanned events
• •Ability to enter data into event management software
• •Ability to oversee training of new employees
• •Ability to track training requirements for team members
• •Ability to order, receive and distribute supplies into production area
• •Ability to push buffer containers ranging from 50L to 200L
• •Ability to sit for periods of 2 to 3 hours
• •Knowledge of autoclaves, process tanks, chromatography skids and columns, analytical equipment
• •Ability to convey information to external stakeholders
• •Ability to oversee support for groups that support manufacturing
• •Ability to lead Continuous Improvement Teams
• •Ability to demonstrate procedures as a part of training sessions
• •Ability to schedule department or process activities
• •Ability to lead team meetings
• •Ability to facilitate multidepartment discussions
• •Ability to provide knowledge in areas of training process improvements
• •Availability for shift, weekend, holiday work and overtime
• •Availability for Wed-Sat 4/3 Overnight Shift, 6p-6:30a

Desired Qualifications

• •Normally requires 3-6 years of related experience required or an associate degree in Life Sciences/Engineering field
• •Biotech Certificate preferred
• •Normally requires 1-4 years of related experience
• •Knowledge of laboratory and pharmaceutical production equipment
• •Able to read and follow detailed written instructions and have good verbal/written communication skills
• •Able to write legibly and grammatically correct entries on records
• •Must be able to author technical procedures and create forms
• •Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
• •Good computer skills, knowledge of Microsoft Word, Excel
• •Good interpersonal skills and be able to work effectively and efficiently in a team environment
• •Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule
• •Ability to work in a clean room environment and comply with hygiene standards and use of special garments
• •Additionally, personal protective equipment must be worn due to safety requirements
• •Working Conditions Normal office working conditions: computer, phone, files, fax, copier
• •Personal Protective Equipment must be worn as required
• •May require lifting amounts of 25 lbs
• •Manufacturing operations tasks requires operator to regularly remain on feet for shift
• •Physical Requirements PPE as required
• •Experience with biologics manufacturing
• •Experience with processing in upstream (cell culture) and downstream (purification)
• •Experience with processing in upstream (cell culture)
• •Experience with downstream (purification)
• •Experience with Akta ready, Akta Process, XDUos buffer systems and disposable technology systems
• •Experience with troubleshooting of the equipment and of process
• •Excellence in clinical manufacturing
• •Characteristics: adaptable to changes
• •Works well cross functionally and with key stakeholders
• •Self-motivated
• •Takes initiative and drives for solutions with the team
• •Can lead in the absence of the manager
• •Could train newer operators once up to speed
• •Other possible responsibilities may include writing deviations/investigations and revising batch records if needed
• •Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities)
• •Strong knowledge and understanding of manufacturing process and equipment to perform various production steps
• •Ability to train employees
• •Subject matter expert operating production equipment, as needed
• •Monitor and record batch parameters, including computer data entry
• •Complete relevant paperwork following GDP/GMP guidelines
• •Perform mathematical calculations related to production processes
• •Initiate new documents for procedures; may make minor revisions to existing documents
• •Work with support team on all necessary event investigations and inventory system cycle counts and discrepancies
• •Troubleshoot process problems and respond to alarms
• •Provide information for unplanned events, including entering data into event management software
• •Oversee training of new employees, track training requirements for team members ensuring appropriate training is completed prior to process execution
• •Order, receive and distribute supplies into production area as needed
• •Pushing buffer containers ranging from 50L to 200L
• •Sitting for periods of 2 to 3 hours
• •Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
• •Convey information to external stake holders (auditors, global colleagues, etc.)
• •Oversee support for groups that support manufacturing (such as external cleaners, etc.)
• •Lead Continuous Improvement Teams (such as 5S, Gemba, OMT, etc.)
• •Demonstrate procedures as a part of training sessions for other team members; may schedule department or process activities which could involve coworkers
• •Lead team meetings and facilitate multidepartment discussions
• •Provide knowledge in areas of training process improvements
• •Such additional responsibilities as the Company may also assign